VIOKASE

Texto original en francés.

Producto de salud natural autorizado en Canadá

Titular

Axcan Pharma Inc.

NPN o DIN-HM

02230019

Estado

Licencia no activa

Fecha de licencia

20 de abril de 2009

Fecha de revisión

1 de noviembre de 2012

Forma

Comprimé

Vía de administración

Orale

Tipo de solicitud

DIN de transition

Composición

Ingredientes no medicinales

Croscarmellose de sodium, Lactose Monohydrate, Talc, Microcrystalline cellulose, Acide stéarique, Silicon dioxide colloïdal

Dosis recomendadas en Canadá

Usos autorizados en Canadá

VIOKASE (pancrelipase, USP) is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis, cystic fibrosis or other conditions.

Texto original en inglés.

Un uso autorizado en Canadá no es una declaración de propiedades saludables autorizada en la Unión Europea. Consulte el registro de declaraciones de propiedades saludables.

Advertencias en Canadá

Cautions and Warnings : VIOKASE and other pancreatic enzyme products are made from pancreatic organs of pigs used for food. The following risks are present with all pancreatic enzyme products including VIOKASE. Potential for Fibrosing Colonopathy: VIOKASE increases the chance of having a rare bowel disorder called fibrosing colonopathy. The condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing. Tell your health care practitioner if you have a history of intestinal blockage or fibrosing colonopathy. Potential for Irritation to the Mouth: Do not retain VIOKASE in the mouth. VIOKASE should not be crushed or chewed. Potential for Hyperuricemia: Increase in blood uric acid levels, which for example, may be associated with worsening of gout, or painful, swollen joints. Tell your health care practitioner if you have gout, kidney disease, or a condition called hyperuricemia. Potential for Allergic Reactions: Symptoms of an allergic reaction include: Trouble with breathing, skin rashes, or swollen lips. Tell your health care practitioner if you are allergic to pork (pig) products. Potential for Viral Exposure from the Product Source: There is a theoretical risk of contracting a viral infection from pig-derived medicines but no human illness has been reported. Contact your health care practitioner right away if you have any of the symptoms listed above. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity, genetic toxicology, and animal fertility studies have not been performed with pancreatic enzyme products derived from pigs. Pregnancy: Tell your health care practitioner if you are pregnant or planning to become pregnant. It is not known if VIOKASE will harm your unborn baby. Nursing Mothers: Tell your health care practitioner if you are breast-feeding or plan to breast-feed. It is not known if VIOKASE passes into your breast milk.

Texto original en inglés.

Cautions and Warnings : Cautions and Warnings/Information for Health Care Practitioners: VIOKASE and other pancreatic enzyme products are made from pancreatic organs of pigs used for food. The following risks are present with all pancreatic enzyme products including VIOKASE. Potential for Fibrosing Colonopathy: Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products. Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with high-dose pancreatic enzyme use, usually over a prolonged period of time and most commonly reported in pediatric subjects with cystic fibrosis. The underlying mechanism of fibrosing colonopathy remains unknown. Doses of pancreatic enzyme products exceeding 6,000 lipase units/Kg of body weight per meal have been associated with colonic stricture in children less than 12 years of age. Subjects with fibrosing colonopathy should be closely monitored because some subjects may be at risk of progressing to stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs. It is generally recommended, unless clinically indicated, that enzyme doses should be less than 2,500 lipase units/Kg of body weight per meal (or less than 10,000 lipase units/Kg of body weight per day) or less than 4,000 lipase units/g fat ingested per day. Doses greater than 2,500 lipase units/Kg of body weight per meal (or greater than 10,000 lipase units/Kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Subjects receiving higher doses than 6,000 lipase units/Kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range. Potential for Irritation to Oral Mucosa: Care should be taken to ensure that no drug is retained in the mouth. VIOKASE® should not be crushed or chewed. These actions can cause early release of enzymes, irritation of oral mucosa, and/or loss or enzyme activity. Potential for Hyperuricemia: Caution should be exercised in subjects with gout, renal impairment, or hyperuricemia. Porcine-derived pancreatic enzyme products contain purines that may increase blood uric acid levels.

Texto original en inglés.

Fuente

Ficha oficial de Health Canada, licencia 02230019

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias, consultado el 27 de octubre de 2026.

Contient des informations visées par la Licence du gouvernement ouvert – Canada (Santé Canada, BDPSNH)

Texto original en francés.

La fórmula vendida en Europa con el mismo nombre puede ser diferente. Esta información no sustituye el consejo de un médico o farmacéutico.

Lista en la revisión oficial del 1 de noviembre de 2012 (registro: Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias).

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